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Aspen Pharmacare Holdings Limited - Aspen and US-based Gilead enter into ARV deal Aspen Pharmacare Holdings Limited (Incorporated in the Republic of South Africa) (Registration number 1985/002935/06) Share code: APN ISIN: ZAE000023586 Press Release Monday, April 25, 2005 Aspen and US-based Gilead enter into ARV deal Foster City, CA, and Johannesburg, South Africa. Leading research based pharmaceutical company, Gilead Sciences, Inc. (Nasdaq: GILD) and JSE Securities Exchange listed Aspen (APN) today announced that the companies have signed a letter of intent to enter into a non-exclusive licensing and distribution agreement for Gilead"s anti-retroviral (ARV) products TruvadaRegistered (emtricitabine and tenofovir disoproxil fumarate) and VireadRegistered (tenofovir disoproxil fumarate). Aspen will manufacture finished product for the 95 resource-limited countries included in Gilead"s global Access Program and will distribute the products in Africa. Stephen Saad, Aspen Pharmacare Group CEO, said "this initiative between Aspen and Gilead further lightens the burden on ARV global capacities and enables both companies to expand access and affordability of key Aids medication to some of the world"s most resource constrained countries, who also happen to be the ones hit hardest by the HIV/Aids pandemic. This collaboration with Gilead, who are one of the world" leading anti-viral research and scientific based company"s further underscores the manufacturing, quality and technical capabilities of Aspen and displays how north-south collaboration can be used to provide solutions to some of the world"s biggest socio-economic challenges." "Gilead has continually explored ways to broaden and expedite access to our antiretrovirals in resource-limited parts of the world where HIV is impacting the lives of so many individuals," said John C. Martin, PhD, President and Chief Executive Officer, Gilead Sciences. "We share this goal with Aspen Pharmacare, and this collaboration allows us to ensure safe and effective HIV therapy reaches as many people as possible." Under the terms of the proposed collaborative agreement, Aspen will manufacture Truvada and Viread, according to U.S. standards for Good Manufacturing Practices (GMP), and distribute the products under their global trade names in specified countries. Gilead will provide active pharmaceutical ingredient (APIs) for its products to Aspen and will transfer the necessary technology for tableting of the products in Aspen"s US Food and Drug Administration (FDA) approved facilities in South Africa. In addition, Aspen will pursue regulatory approval for the products in the African territories where these two products are unregistered at this point. Aspen has agreed to sell the products at the developing market access prices through Gilead"s global Access Program. The companies anticipate finalizing this agreement by the latest September 2005. Viread and Truvada are newer generation ARVs used in combination with other ARVs and will significantly complement Aspen"s existing ARV range of products. The importance of an expanded pipeline of ARVs is critical to the future management of AIDS patients as the potential mutation of the HIV virus and potential resistance to existing ARV treatments futuristically surfaces. Saad went on to comment that,"Aspen is highly committed to providing a comprehensive ARV offering and keeping abreast of the latest pharmaceutical developments in the evolution of ARVs. This collaboration with Gilead continues to keep Aspen at the forefront of AIDS treatment and further enhances Aspen"s already comprehensive ARV pipeline of ARVs." Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company"s mission is to advance the care of patients suffering from life- threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia. Aspen is the leading listed pharmaceutical company on the JSE Securities Exchange and the African continent"s largest pharmaceutical manufacturer. Aspen is a major supplier of branded pharmaceutical and healthcare products to the African continent and selected international markets and also the largest supplier of generics to both the private and public sectors in South Africa. Aspen has an extensive basket of quality, effective and affordable products in the branded, generic, over-the-counter (OTC), personal care, fast moving consumer goods (FMCG), nutriceutical and infant nutritional formulations (INFs) categories. Aspen is also acknowledged as the world"s first pharmaceutical manufacturer to be granted approval by the US Food and Drug Administration (FDA) to manufacture combination therapy ARVs in a co-packed form. ends Issued by: Shauneen Beukes, Shauneen Beukes Communications Tel: (012) 661-8467 Fax: (088) (012) 6618467 Cell: 082 389 8900 On Behalf Of: Stavros Nicolau, Aspen Senior Executive: Group Strategic Trade Tel: (011) 239 6798 Fax: (011) 239 6018 Cell: 082 458 3135 Date: 25/04/2005 02:00:07 PM Supplied by www.sharenet.co.za Produced by the JSE SENS Department
